1. Field of the Invention
The invention relates to methods and devices for forming an anastomosis between two hollow bodies, and more particularly to forming an anastomosis using magnetic force.
2. Description of Related Art
Despite the considerable advances that have been realized in cardiology and cardiovascular surgery, heart disease remains the leading cause of death throughout much of the world. Coronary artery disease, or arteriosclerosis, is the single leading cause of death in the United States today. As a result, those in the cardiovascular field continue to search for new treatments and improvements to existing treatments.
Coronary artery disease is currently treated by interventional procedures such as percutaneous transluminal coronary angioplasty (PTCA), coronary stenting and atherectomy, as well as surgical procedures including coronary artery bypass grafting (CABG). The goal of these procedures is to reestablish or improve blood flow through occluded (or partially occluded) coronary arteries, and is accomplished, for example, by enlarging the blood flow lumen of the artery or forming a bypass that allows blood to circumvent the occlusion. What procedure(s) is used typically depends on the severity and location of the blockage. When successful, these procedures restore blood flow to myocardial tissue that had not been sufficiently perfused due to the occlusion.
Another proposed treatment places the target vessel, e.g., a coronary artery, in direct fluid communication with a heart chamber containing blood, for example, the left ventricle. Blood flows from the ventricle into a conduit that is in fluid communication with the artery; as such, this treatment may be described as a ventricular bypass procedure. Benefits of this procedure include obviating the need to manipulate the aorta, for example, as is done when a side-biting clamp is used in a typical CABG procedure to create a proximal anastomosis between the bypass graft and the aorta. Clamping or otherwise manipulating the aorta places the patient at risk in some cases due to the likelihood that such manipulation will release embolic material into the bloodstream. Some challenges associated with this procedure include delivering and deploying the conduit in the patient""s body, properly positioning the conduit with respect to the heart chamber and the target vessel, and obtaining beneficial flow characteristics through the conduit and the target vessel.
A particularly challenging task that must be performed during CABG procedures (as well as some ventricular bypass procedures) is suturing the conduit to one or more vessels. As an example, one end of the conduit may be sutured to a source of blood, such as the aorta, a heart chamber or a blood vessel, while the other end of the conduit is sutured to the target vessel, such as a coronary artery or another blood vessel. The small diameter of the vessels involved (typically from 1 mm to 4 mm) makes creating a handsewn anastomosis a highly technical and time-consuming procedure. The difficulty in forming the sutured anastomosis is exacerbated when access to the target vessel is restricted or limited, as in a minimally invasive or percutaneous procedure. This problem also arises in non-cardiovascular applications that utilize handsewn anastomoses, for example, treating peripheral vascular disease or injury, creating AV (arteriovenous) shunts, etc.
While those in the art have proposed various anastomotic couplings intended to replace a sutured anastomosis, none has performed well enough to receive any significant level of acceptance in the field. Many of the proposed couplings penetrate or damage the target vessel wall acutely or chronically, do not remain patent, fail to produce a fluid-tight seal between the conduit and vessel, or are simply too cumbersome and difficult to deliver or deploy.
Accordingly, there is a need in the art for methods and devices for forming a reliable anastomosis between hollow bodies in a relatively quick, easy and repeatable manner as compared to handsewn anastomoses or anastomoses formed by prior art, suture-free devices.
According to one embodiment, the invention provides a method using magnetism for forming an anastomosis between first and second hollow bodies. Each hollow body has a lumen and an opening extending into the lumen. The method is carried out by positioning a first securing component adjacent the opening in the first hollow body, positioning a second securing component adjacent the opening in the second hollow body, and using magnetic force to form an anastomosis between the first and second hollow bodies with the lumens of the first and second hollow bodies in communication.
According to another embodiment, the invention provides a method using magnetism for forming an anastomosis between first and second hollow bodies, each of which has a lumen. The method uses magnetic force to form an anastomosis between first and second hollow bodies so as to place their lumens in communication. The first hollow body has proximal and distal portions between which the anastomosis is disposed.
According to another embodiment the invention provides a method using magnetism for forming an anastomosis between first and second hollow bodies with lumens and openings extending into the lumens. This method is performed by positioning a first securing component adjacent an opening in the first hollow body, positioning a second securing component adjacent an opening in the second hollow body, and using magnetic force to form an anastomosis between the first and second hollow bodies with the lumens of the first and second hollow structures in communication. At least one of the securing components is positioned without everting the hollow body.
According to still another embodiment, the invention provides a method using magnetism for forming an anastomosis between first and second hollow bodies by positioning a first securing component adjacent the first hollow body, positioning a second securing component adjacent the second hollow body, and using magnetic force to control the relative position of the first and second securing components and to form an anastomosis between the first and second hollow bodies. The blood-carrying lumens of the first and second hollow bodies are placed in communication, with at least one of the first and second securing components at least partially disposed within the blood-carrying lumen of one of the first and second hollow bodies.
According to another embodiment of the invention, a method for forming an anastomosis between first and second hollow bodies may or may not use magnetism to facilitate the anastomosis. This method includes steps of positioning a first securing component through an opening in the wall of the first hollow body and at least partially within the lumen of the first hollow body, positioning a second securing component adjacent the second hollow body, applying a coupling force to the first and second securing components without penetrating the wall of the first hollow body, and forming a seal between the first and second hollow bodies while placing the lumens of the first and second hollow bodies in communication. The coupling force is applied at substantially the same location at which the seal is formed.
According to yet another embodiment, the invention provides a system for forming an anastomosis between first and second hollow bodies in a patient""s body. The system includes first and second securing components capable of producing a magnetic field that applies force to maintain the securing components in a desired relative position. The first securing component has an opening and is substantially plate-shaped and sized and configured to be at least partially received in a lumen of a hollow body in a patient""s body, and the second component has an opening and is sized and configured to be positioned adjacent a second hollow body in the patient""s body for forming an anastomosis between the first and second hollow bodies.